Ethical Approval for Research
Ethical Approval for Research
All research is subject to ethical scrutiny. However, only research involving human participants or their data or research involving animals requires ethical approval.
Before you start your research confirm that you need ethical approval for your research
Get familiar with:
- Trinity’s Policy on Good Research Practice
- Data Protection at Trinity:
- Trinity’s Data Protection Policy and Handbook. Official Trinity templates for the required consent forms and PILs can be found here.
- GDPR training is provided by the Data Protection Office for all those processing or conducting or supervising research involving Personal Data of Participants
- Research Integrity at Trinity:
- PhD candidates are automatically enrolled in the Blackboard CA7000 Research Integrity module
- All other staff and students should avail of the Epigeum Research Integrity training
- Any other requirements specific to your faculty, school or discipline.
Ensure the following are in place:
- Enough time: depending on the nature of the research, applications can take a long time to complete
- Complete Trinity’s training modules for Data Protection and Integrity in Research
- Permissions to contact participants are in place, recruitment materials and consent forms are prepared
- Garda Vetting completed if required
- Data Collection instruments developed
- Interventions or experiments designed
- Confirmation whether your research qualifies as Health Research
- If you are using non-Trinity sites or collaborating with researchers from another institution you may also need:
- Ethics approvals from committees outside of Trinity where necessary
- Licences or permits to access non-Trinity sites and/or secondary data sources
- Data Protection Risk or Impact Assessments (DPR/I As) for non-Trinity sites
- Data sharing contracts
Prepare any relevant documents pertaining to the above as they will be required as attachments for the Application.
Making an Ethical Application: made easier with the Research Ethics Application Management System (REAMS)
The Research Ethics Application Management system (REAMs) is a new platform developed for processing research ethics applications.
From January 2023: all applications from Staff researchers or PhD students should be made through REAMs
Start your application here. Help text boxes pop up as you go through the application providing links to more information in a comprehensive guidance document which is navigable by contents headings or key words to help you complete your application
Click here to access the Research Ethics Application Management System
Frequently Asked Questions
Making an Application (last updated 4.01.2023)
What are the key features of the platform? | REAMs is a web-based platform that allows you to submit an application for ethical review directly to the most appropriate Research Ethics Committee. It uses a combination of yes/no questions, drop down menus and text boxes to complete an application. New applications and amendments to current applications are selected for. The Submissions tab shows all your applications with their unique reference number and status ie where in the process they are. You can download applications in word form. |
How does the platform work? | It’s a responsive system that expands in response to answers you give to key questions thereby only revealing information specific to your application The platform: |
What are the major differences between REAMs and the current system? | There are now 3 risk levels (level 1-3) and the appropriate level of review is automatically determined by the application. |
How do I know the status of my application? | Email notifications are sent out from the noreply@academic.ie to confirm when your application is submitted and when a decision has been made by the REC. A record of emails sent is available in the ‘Notifications’ pane on your REAMs homepage. The ‘Submissions’ tab shows the status of the application eg. awaiting review. The person icon on the ‘Submissions’ tab opens up an audit trail of completed steps and gives access to any comments returned from the REC. |
There are Errors. What does this mean? | You will have errors if you have not completed all required fields or have not uploaded all required attachments. To identify fields you have missed open a section, press save and incomplete fields will appear as outlined in red. The platform will not let you submit until the errors are all addressed. Tips: Clicking on each error doesn’t take you back to where in the application so address these before you move on to each page/section to prevent them building up as you go. |
What are the attachments and why do I have to do them? | The Attachments are like the Appendices REAMS makes a running list of required appendices relevant to your specific application. You cannot submit an application unless all required attachments have been uploaded To upload attachments: Tips |
Is there any help available? | There is Help text in a blue shaded box in every section of application that has some high level hints and links to templates, and to the accompanying Guidance Document Applicant support is available on our website here including background, guidance, and a ‘making an application’ video. |
How do I log-in? |
Go to https://www.ethics.tcd.ie
Go to https://www.ethics.tcd.ie |
Is it possible to log-in via a group email? |
Has to be an individual email address due to how the authentication works at log-in |
Can I change my personal details? | You can customise your profile in REAMS, for example by adding a picture. |
Can I see an application form in totality? | Upfront overview of sections is not possible: NB. Super questions ‘wholly’/ ‘only‘ |
What if I have external ethical approval already eg JREC do I still need to complete an application in REAMs? | Yes. You can indicate that you have ethical approval from another committee and will be asked to upload the approval as an attachment. |
Where do I get the data protection application form? |
There is a Data Protection section as part of an application in REAMs. If a DPIA is required, it will be included in the Data Protection Section. If you are asked to complete this section, the Data Protection Office will be one of the reviewers of your application. A TCD DPIA is approved by TCD DPO. If you have been required to complete a DPIA for another research site you can uploaded this as an attachment |
Where do I get my consent forms? | There are two different consent forms you may be asked to develop: Links to templates for each can be found in the blue shaded help text and in the Guidance Document |
Is there a particular PIL to use? | There are 3 possible templates for the PIL.
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What do I choose-I am staff and a student? |
This depends on your role in the research. |
Why does the system need to capture employer details? |
This informs the REC if applicants have other affiliations relevant to the application eg staff with a hospital position, or part-time students in professional employment |
Why do collaborators need to be recorded? | This gives the REC information about the other members of the Research Team Students add their academic supervisor as a TCD collaborator. Non-PI applicants add the PI as a TCD Collaborator Any TCD collaborator can coedit the application in draft form and also non-TCD collaborators (they have to be pre-registered on system) can have full read access to the application.
The only collaborators required to sign the application are the PI or supervisor |
Do I still apply directly to the REC at Faculty or School Level? | REAMs determines the most appropriate REC to review your application using information about your School and the risk level. You do not have to identify the REC before starting an application. |
What if I click on the wrong school?
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If you click on the wrong school it will automatically direct to that REC |
Do I have to complete training (research integrity, GDPR) in advance of a REAMs application? |
The REAMs platform is neutral: If say ‘yes’ system will require certs as proof in the attachment list and so the application cannot proceed until this is done. Reports will show the extent of the issue ie. number of submissions without training completed. |
Who officially signs off the application? | Applicants sign off as the last step before submission Only one digital signature is required in REAMs rather than all researchers/collaborators in a team All sign-offs are recorded digitally on the REAMs platform. |
Can colleagues collaborate to help complete my application?
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In draft form, before submission, it is possible to allow collaboration on a document by team members including the PI/supervisor; possible even if collaborators are outside TCD although they can read only. NB. Take care not to override editing-best to do offline and then cut and paste into the application. A safeguard will be built-in to the next version 2. |
What’s the difference in the definitions of risk in the: |
Risk tab/section is about risk a project poses to each of the researcher(s), participant(s), and site(s) where research is done. DP risk is for data processing risk solely: filling this out is important to inform whether or not a DPIA will be needed Risk Level is the level of review that the project requires. Projects are assigned automatically to Level 1, 2, or 3. |
The word limit for a text field is not large enough for me to include all the information relevant to that field. What should I do? | Word limits are designed to encourage precision and efficiency in describing your study. If the word limit for any text field is insufficient you can upload the entry as an attachment – under Document Type select ‘Other Documentation’ and in the text field enter ‘REF Attachment [NAME]’ Where there is not enough space then: |
Do even Level 1 research projects have to go to full ethical review? | There is an option, where the supervisor or PI believes the research does not meet the threshold for ethical review, for the application to be ‘approved without review’ but |
I’ve noticed that the platform requests the External Ethical Approval form but I haven’t received it yet-can I get TCD approval pending receipt of this? | REAMs cannot offer any ‘approval in principle’. Where external ethical approval is required it must be achieved before applying to TCD through REAMs. All approvals must be received prior to TCD approval to ensure that the research achieves the correct level of ethical/ data protection scrutiny. However, there may be instances where individual sites or sources require specific ethics approval-see below for how to manage these situations |
My research requires approvals (licences/permits/ethics) from a site or source but I have yet to obtain it, what should I do? | In cases where there are several sites/sources requiring licences/permits or providing ethics approval, it is recognised that, in some instances, not all permissions will have been secured before the application is submitted to the REC. In such cases, a REC may grant approval for the research to proceed at the sites for which licences/permits have been secured or ethics approval has been granted. In Project Details, under Add Data Collection site/source select the option ‘Site/Source ethics required but not yet obtained from this site’ Approval for the conduct of research at additional sites may be requested subsequently through an application for an amendment to the proposal. NB. Please note that approval on the basis of Expedited Review will not be granted without all the necessary licences/permissions or ethics approvals being in place. |
What signifies an application as an E expedited?
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If the Risk level includes the letter E this signifies that an application may be eligible for expedited or Chair review (where practiced by a REC). |
What determines whether an application may be deemed eligible for Chair review is the answer given? | Approval from an external ethical approver and/or low risk method eg. |
What if I have made a mistake in the submission, I cannot seem to change it? | When you press SUBMIT the application cannot be edited unless it is reset to draft. Requests to reset to draft need to made by direct email to the next person in the workflow. |
What’s the difference between Administrative Data and research data? | Administrative data is contact information for recruiting participants whereas research data is the data that is collected and processed/analysed as part of the research, to be used as findings.
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What are the timelines for submission, feedback, approval? | Each REC operates to its own deadlines for submission and time-lines for review. Information should be available on the REC website. |
How do I make changes to the application when I’ve heard back from the REC | There is no way to track changes in the application by emboldening or colour change so it is advisable to download a word copy of your original application and then compare this to the feedback and do the changes and save as a revised version and resubmit that. |
What if something changes in my research protocol-how do I make an Amendment? | When you click on ‘New Ethics Application’ you are asked to indicate if this is a new application or an amendment. |
What follow-up documentation will I be asked to submit if any? |
Prompt emails will be sent from noreply@academic.ie to remind you to submit an end of project report. It will also be essential to upload any adverse incidents that occur during your research |
Why am I asked to enter information about the countries where I will collect data? | This simply alerts the REC if research is being conducted in ‘no go’ countries
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Why is there no option for Northern Ireland?
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If NI then choose UK even though in collecting data it is often treated like an extension of Ireland. |
How does REAMs handle Mixed Methods studies (eg. 1st qual/ 2nd quant) |
Can be handled in 2 different ways: |
Are my previous drafts saved? |
No previous drafts are retained so you must download them as a ord document if you wish to retain them for reference or to track changes. |
Why can’t I see the name of the reviewers and their individual comments? | This anonymity in an important part of the ethical review process. |
Is it Ok to say no to a question eg consent?
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Yes, the REC is the ultimate decision-maker and will feedback if incorrect. |
How does REAMs interface with research in hospitals.
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REAMs does not interface with eg. JREC. It (and other hospital RECs) are a separate entity and will be treated by TCD as an external REC ie approval must be granted by the hospital REC before any application can be processed by TCD. |
How does REAMs interface with Animal Research-lab? | REAMs forwards to AREC. This is the same process as before but REAMs now records this research for reporting purposes. |
How to add more labs/ more countries to a study? | This is done by making amendment (see Amendment FAQ) You will be asked what study you are amending to ensure the amendment is linked back to the original application
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I am a professional staff member conducting research with no affiliation to any school or faculty so what REC will my application be assigned to? | Research Ethics Committees are located in academic Schools and Faculties. |
If I put in multiple applications, do I have a better chance of getting approval quicker?
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No, you should work on one application, the time taken is related to the REC’s processes not the REAMs platform. |
Can I apply for ethics from a TCD REC if I am not a Staff member or registered student of TCD? |
The current policy is available here |